Transparency of AI/ML-enabled Medical Devices - Virtual Public Workshop – October 14, 2021

Register to attend by 4:00 p.m. ET on October 13, 2021

If your email program has trouble displaying this email, view as a webpage. FDA Public Workshop to Discuss Transparency of Artificial Intelligence and Machine Learning-enabled (AI/ML-enabled) Medical Devices The U.S. Food and Drug Administration's (FDA's) Digital Health Center of Excellence will hold a free virtual public workshop, Transparency of Artificial Intelligence/Machine Learning-enabled Medical Devices. The purpose of this public workshop is to identify unique considerations in achieving transparency for users of AI/ML-enabled medical devices and ways in which transparency might enhance the safety and effectiveness of these devices. It also seeks to gather input from various stakeholders on the types of information that would be helpful for a manufacturer to include in the labeling and public facing information of AI/ML-enabled medical devices as well as other potential mechanisms for information sharing. Workshop Date: Thursday, October 14, 2021 Location: Virtual; a link to the live webcast will be provided in your confirmation email Registration Deadline: 4:00 p.m. on Wednesday, October 13, 2021 Learn More Request for Input The FDA is seeking your input on this topic at the workshop. You can also submit your written comments regarding the topic of this workshop to the docket (FDA-2019-N-1185-0001) by November 15, 2021. Requests to present during the open public comment session of the workshop can be submitted during registration and must be received by September 3, 2021.   About the Digital Health Center of Excellence Launched in September 2020 and located in the Center for Devices and Radiological Health (CDRH), the Digital Health Center of Excellence is committed to strategically advance science and evidence for digital health technologies within the framework of the FDA's regulatory and oversight role. The goal of the Digital Health Center of Excellence is to empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation. Questions? If you have questions about this public workshop, please email AI-MLTransparencyWorkshop2021@fda.hhs.gov.

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